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Venezuela's leader visits, vows to invest in Benin
Topix - Sunday, August 13, 2006
Venezuela President Hugo Chavez wrapped up a two-week world tour and headed home after a brief visit to the tiny West African nation of Benin, where he pledged to invest in one of the world's poorest ... more

Grants Target Safety and Health Outreach in Developing Countries
Topix - Sunday, August 13, 2006
OEHS organizations in Venezuela, China, the Republic of Benin and Serbia and Montenegro are the recipients of the 2005 Worldwide Outreach Program grants from the Foundation for Occupational Health and Safety , ... more

Benin, Venezuela advocate UN reform
Topix - Sunday, August 13, 2006
Presidents Yayi Boni Yayi of Benin and Hugo Chavez of Venezuela on Wednesday renewed calls for reforms that would reflect "more democracy" within the United Nations ... more

Full Issue in PDF Format
FDAnews - Sunday, August 13, 2006
View the entire issue in PDF ... more

Adjustments to CMS Final Rule Brighten Prospects for Device Firms, Experts Say
FDAnews - Sunday, August 13, 2006
The device industry, which feared a Centers for Medicare & Medicaid Services (CMS) proposal to cut reimbursement rates under Medicare’s inpatient prospective payment system (IPPS), can breathe a sigh of ... more

Regulators, Lawmakers Seek More Oversight of Genetic Test Sales
FDAnews - Sunday, August 13, 2006
Genetic test makers marketing their products for direct-to-consumer sale can expect to find themselves under a regulatory microscope after a government report found some manufacturers are testing the limits of advertising ... more

Clearer Interaction Needed Between Doctors, Firms on Heart Devices
FDAnews - Sunday, August 13, 2006
There is growing consensus that doctors need to work more closely with heart device manufacturers to establish guidelines for managing patients implanted with devices at risk for ... more

FDA Issues Q&A Guidance on HDE Regulation
FDAnews - Sunday, August 13, 2006
The FDA July 25 posted an updated guidance answering common questions about humanitarian use devices (HUDs) and applications for humanitarian device exemptions ... more

Device, Drug Industry Excluded From Anti-Kickback Safe Harbor
FDAnews - Sunday, August 13, 2006
HHS is excluding device and drugmakers from a new protection from the anti-kickback statute designed to promote adoption of electronic health records, arguing that these sectors cannot be trusted to abide by the ... more

Cardiac Science Receives Warning Letter for AEDs
FDAnews - Sunday, August 13, 2006
Cardiac Science, Bothel, Wash., received an FDA warning letter saying its automated external defibrillators (AEDs) are adulterated because of nonconformity with current good manufacturing practice ... more


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Gurney Maker Says User Error Led to FDA Warning Letter
FDAnews - Sunday, August 13, 2006
The FDA warned the maker of a shower gurney that it was in violation of the agency’s reporting requirements after an incident in which a nursing home resident fell out of the gurney and was ... more

Briefs
FDAnews - Sunday, August 13, 2006
... more

Device Recalls
FDAnews - Sunday, August 13, 2006
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FDA: SUBSTITUTE SALIVA IS A REGULATED DEVICE, NOT COSMETIC
FDAnews - Sunday, August 13, 2006
In a July 10 warning letter, the FDA told the maker of a dry mouth reliever that its product is considered a saliva substitute, and therefore should be regulated as a medical ... more

FDA DEVELOPING TEST TO SCREEN FOR HOAX BIOTERROR AGENTS
FDAnews - Sunday, August 13, 2006
Researchers at the FDA's National Center for Toxicological Research are developing a new way to screen for and identify bioterror agents and other substances used in hoax incidents, the agency announced Aug. ... more

SENATE BILL TO DELAY DRA IMAGING CUTS GETS SUPPORT FROM RADIOLOGY GROUP
FDAnews - Sunday, August 13, 2006
The American College of Radiology (ACR) said Aug. 4 it strongly supports S. 3795, the Access to Medicare Imaging Act, which calls for a two-year moratorium on medical imaging reimbursement cuts included in the Deficit Reduction Act of 2005 ... more

FDA ISSUES GUIDANCE ON FISCAL 2007 SMALL BUSINESS QUALIFICATION AND CERTIFICATION UNDER MDUFMA
FDAnews - Sunday, August 13, 2006
The FDA Aug. 3 posted a guidance issued Aug. 1 on small business qualification and certification under the Medical Device User Fee and Modernization Act ... more

THERAGENICS ACQUIRES DISPOSABLE MEDICAL DEVICE COMPANY
FDAnews - Sunday, August 13, 2006
Medical device company Theragenics Corp. has bought Galt Medical Corp. for $31.9 million to diversify its medical device and surgical ... more

TOMOTHERAPY RADIATION TREATMENTS BEGIN IN GERMANY
FDAnews - Sunday, August 13, 2006
TomoTherapy Incorporated announced that the University Clinic Heidelberg became the first German institution to treat cancer patients with the TomoTherapy(R) Hi-Art ... more

KOREA ON TRACK TO BECOME BIOTECHNOLOGY LEADER
FDAnews - Sunday, August 13, 2006
Fourteen years since the launch of the national research and development program in 1982, Korea still has a long way to go in achieving its ambitions of becoming a biotechnological world ... more

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